MAUDE Adverse Event Report: ABBOTT VASCULAR DRAGONFLY¿ OPTIS¿ IMAGING CATHETER; DIAGNOSTIC INTRAVASCULAR CATHETER

Model Number C408645

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2022

Event Type  malfunction  

Event Description

It was reported that a leak of the lumen junction was found when the dragonfly catheter was flushed with contrast media.The procedure was successfully completed with a new dragonfly optis catheter.There was no patient involvement.The return device analysis identified that the outer sides of the x-ring retainer proximal seal was pushed upwards and no longer perfectly round while seated inside the x-ring retainer.Once the seal was removed from the x-ring retainer the shape of the seal returned to its normal shape (round).There were separated pieces of the x-ring retainer proximal seal material in the lower left corner.There were strands of shredded material next to the material separation noted.The seal was then flipped over and a split in the x-ring retainer proximal seal was observed in the upper left corner.There were strands of shredded material next to the split noted.No additional information was provided.

Manufacturer Narrative

Visual analysis, functional testing, and additional analysis were performed on the returned device.The reported leak issue was able to be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A query of the complaint handling database for the reported lot was performed and revealed there is no indication of a lot level quality product issue.The investigation determined that the reported leak issue was related to circumstances of the procedure.Based on the analysis of the returned device, the cause of the leak was likely breakaway joint separation which likely caused the x-ring retainer proximal seal damage; however this could not be confirmed.It could be that the customer encountered excess distal pressure/restriction during use, which caused a separation of the breakaway joint, thus causing the observed leak.Other possible causes for the leak could be damage to the catheter sheath, excess bending of the strain relief causing catheter damage, or over pressurization of the syringe during use; however, these conditions could also not be confirmed.Based on the returned state of the device, the leak and observed damage occurred outside the patient and during attempted device prep.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: DRAGONFLY¿ OPTIS¿ IMAGING CATHETER
• Type of Device: DIAGNOSTIC INTRAVASCULAR CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT MEDICAL REG#3009600098; 4 robbins rd; westford MA 01886
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15721251
• MDR Text Key: 304013175
• Report Number: 2024168-2022-11197
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000647
• UDI-Public: 00183739000647
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K141769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2023
• Device Model Number: C408645
• Device Catalogue Number: C408645
• Device Lot Number: 8114410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OPTIS MOBILE